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Trial Title:
Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer
NCT ID:
NCT05780567
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Tamoxifen
Letrozole
Anastrozole
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
TQB3616 capsules, Letrozole, Anastrozole, Tamoxifen
Description:
TQB3616 is a novel Cyclin-dependent kinase (CDK) 4/6 inhibitor and currently being used
in the treatment of a variety of malignant solid tumors.
Letrozole combined with Anastrozole and Tamoxifen is an endocrine therapy that involves
adding, blocking, or removing hormones. It can be used for conditions that affect hormone
levels, such as breast cancer.
Arm group label:
TQB3616 capsules combined with endocrine
Intervention type:
Drug
Intervention name:
Placebo capsules, Letrozole, Anastrozole, Tamoxifen
Description:
Letrozole combined with Anastrozole and Tamoxifen is an endocrine therapy that involves
adding, blocking, or removing hormones. It can be used for conditions that affect hormone
levels, such as breast cancer.
Arm group label:
placebo combined with endocrine
Summary:
This is a Phase III, randomized, double-blind, parallel, multi-center trail to evaluate
the efficacy and safety of TQB3616 capsule combined with endocrine compared to placebo
compared with endocrine in HR-positive and HER2-negative breast cancer adjuvant therapy.
Approximately 1946 female subjects will be randomized to either TQB3616 combined with
endocrine group or TQB3616-matching placebo combined endocrine group. Randomization will
follow a 2:1 ratio, 1297 subjects in experimental group and 649 in the the Placebo
Comparator group.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- The subjects voluntarily joined the study and signed the informed consent, with good
compliance.
- Age: 18-75 years old (upon signing the informed consent); Eastern Cooperative
Oncology Group Performance Status (PS) score: 0~1;
- Surgical treatment of radical mastectomy;
- Pathological examination confirmed HR positive and HER2 negative invasive breast
cancer;
- The major organs are functioning well, meeting the following criteria：
1. Blood biochemical tests should meet the following criteria (no corrective
therapy has been used within 7 days prior to screening)：
1. Hemoglobin (HB) ≥90 g/L；
2. Neutrophil absolute value (NEUT) ≥ 1.5×109/L；
3. Platelet count (PLT) ≥ 100 ×109/L；
2. Blood biochemical tests should meet the following criteria (no corrective
therapy has been used within 7 days prior to screening)：
1. Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN)；
2. Alanine transferase (ALT) and aspartate transferase (AST) ≤ 1.5×ULN；
3. Serum creatinine (Cr) ≤ 1.5×ULN, or creatinine clearance (Ccr) ≥ 60
ml/min；
3. Blood clotting tests must meet the following criteria (no anticoagulant
therapy)：
1. Prothrombin time (PT) ≤ 1.5×ULN;
2. Activated partial thromboplastin time (APTT) ≤ 1.5×ULN;
3. International Normalized ratio (INR) ≤ 1.5×ULN.
4. Left ventricular ejection fraction (LVEF) ≥50%.
Exclusion Criteria:
- Complicated diseases and medical history:
1. Has had other malignant tumors within 5 years or currently has other malignant
tumors;
2. Have a variety of factors that affect oral medication (such as inability to
swallow);
3. Current history of serious lung disease such as interstitial pneumonia；
4. Severe infections common terminology criteria for adverse events (≥CTCAE
(common terminology criteria for adverse events) 2 grade) that were active or
uncontrolled before the study treatment started (Except hair loss and
hemoglobin)；
- Known allergy to aromatase inhibitors, tamoxifen, TQB3616/ placebo, or any
excipients;
- There was a history of live attenuated vaccine vaccination within 28 days prior to
randomization or live attenuated vaccine vaccination was planned during the study
period;
- Participated in clinical trials of other antitumor agents within 4 weeks prior to
randomization；
- The presence of other serious physical or mental illnesses or abnormalities in
laboratory tests that may increase the risk of study participation or interfere with
the study results, as well as subjects who are deemed unsuitable for study
participation for other reasons by the investigator.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Science
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Contact:
Last name:
Binghe Xu, Doctor
Phone:
+86 13501028690
Email:
xubinghe@medmail.com.cn
Facility:
Name:
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Address:
City:
Guangzhou
Zip:
300020
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Qiang Liu, Doctor
Phone:
+86 18922182851
Email:
liuqiang_sysu@163.com
Facility:
Name:
Suining Central Hospital
Address:
City:
Suining
Zip:
629099
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongwei Yang, Master
Phone:
+86 18008258079
Email:
snsyhw@163.com
Start date:
March 30, 2023
Completion date:
January 2027
Lead sponsor:
Agency:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Agency class:
Industry
Source:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05780567
